Research Methodology, the Regulatory Process & Ethics
Presented jointly by the Vice President's Office for Research & Graduate Studies the School of Medicine
Date: Thursday, November 8, 2007
Time: 8:00 am – 11:00 am
Location: MR-5 Room 3005 (3rd floor, classroom on the right)
Full breakfast will be provided
See information regarding Continuing Medical Education (CME) credit and faculty disclosures on the next page
Agenda:
Time Topic Presenter
8:00 Welcome and Introduction David Hudson
8:15 Clinical Research Design: Implications for Review and Regulation Viktor Bovbjerg
9:00 Delegation of Authority – A Clinical Research Coordinator Perspective Sandra Burks
9:30 Break
9:45 The Role of the IRB in Clinical Research Karen Schwenzer
10:15 Post-Approval Compliance Monitoring: Tips for Ensuring Success Karen Parks
10:30 Distinguishing Clinical Research from Medical Care Ronald Turner
11:00 Evaluation and Conclude
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Speakers:
David Hudson, PhD, Associate Vice President, Office of Research Graduate Studies
Viktor Bovbjerg, PhD, MPH, Associate Professor of Epidemiology & Biostatistics, Department of Public Health Sciences
Sandra Burks, RN, BSN, CCRC, Associate Director, Surgical Therapeutic Advancement Center
Karen Schwenzer, MD, FCCM, Associate Professor of Anesthesiology, and Chair, IRB for Health Sciences Research
Karen Parks, BSN, RN, CCRP, Post Approval Compliance Monitor
Ronald Turner, MD, Professor of Pediatrics, and Associate Dean for Clinical Research
The University of Virginia School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.
The University of Virginia School of Medicine designates this educational activity for a maximum of three AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.
The University of Virginia School of Medicine awards 0.1 CEU per contact hour to each non-physician participant who successfully completes this educational activity. The CEU (Continuing Education Unit) is a nationally recognized unit of measure for continuing education and training activities that meet specific educational planning requirements. The University of Virginia School of Medicine maintains a permanent record of participants who have been awarded CEUs.
Faculty Disclosure Information for Research Methodology, the Regulatory Process & Ethics
Dr. Ronald Turner has disclosed that he has a relevant financial relationship as an independent contractor (research and clinical trials) and/or consultant for Procter & Gamble Co., Dial Corporation, and Warner Lambert/Pfizer.
Dr. David Hudson, Dr. Viktor Bovbjerg, Sandra Burks, Dr. Karen Schwenzer and Sarah Blackman have disclosed that they do not have a financial relationship or interest with any proprietary entity producing healthcare goods or services.